NCT00171574已完成4 期
Antiproteinuric Effect of Valsartan, Lisinopril and Valsartan Plus Lisinopril in Non-diabetic and Diabetic Renal Disease: a Randomized, Double Blind, Parallel Group, Controlled Trial With 5 Months Follow-up
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change from baseline in urine protein excretion after 20 weeks
研究概览
简要总结
Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group, controlled trial, 5 months follow-up.
Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo treatment in no-diabetic and diabetic patients.
Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin ratio more than monotherapies.
Design: Multicentric, randomized, double blind, parallel group, active controlled.
Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged 18-70 years,
- •Chronic nephropathy, as defined by a serum creatinine concentration of > 3 mg/dL or calculated glomerular filtration rate of > 30 mL/min/1.73 m
- •Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ).
- •Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: <125/75 mmHg).
- •Written informed consent to participate in the study prior to any study procedures.
排除标准
- •Immediate need for renal replacement therapy.
- •Treatment resistant oedema.
- •Need for treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs.
- •Proteinuria greater than 10g /24h and/or hypoalbuminaemia less than 28g/L.
- •Renovascular hypertension
- •Malignant hypertension
- •MI, cerebrovascular accident within last year, severe peripheral vascular disease, CHF, chronic hepatic disease.
- •Angiotensin converting enzyme inhibitors and angiotensin II receptors blockers within one month prior to randomization.
- •A serum creatinine concentration >265 ümol/L
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline in urine protein excretion after 20 weeks
次要结局
- Change from baseline in a laboratory measure of kidney function after 20 weeks
- Change from baseline in systolic blood pressure after 20 weeks
- Change from baseline in diastolic blood pressure after 20 weeks
研究者
研究点 (1)
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